Multiple MyelomaPhase 2NCT02086942
Tolerability and Efficacy of Modified VCD Regimens in Previously Untreated Multiple Myeloma.
A Phase 2 study testing Bortezomib, cyclophosphamide and Dexamethasone in people with Multiple Myeloma, run by Yongping Zhai at 1 site in China.
Trial summary
This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to August 2017.Firstly, All patients included will provide written informed consent. Secondly, they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD regimen arm 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib, cyclophosphamide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previously untreated symptomatic MM
- 18 years of age or older, regardless of gender
- secretory MM with measurable diseases
- Karnofsky Performance Status≥50%（pathological fractures excluded）
- Patients without heart and pulmonary dysfunction ≤class I
Who cannot join
- peripheral neuropathy of grade 2 or higher according to NCI-CTCAE Version 3.0
- Relapse and refractory MM
- MM without symptom
- Non-secretory MM without measurable diseases
- Karnofsky Performance Status<50%（pathological fractures excluded）
- Patients with heart and pulmonary dysfunction> class I
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
zhai yo ping, doctor, 13951947646, ypzhai@medmail.com.cn
About this study
Official title: Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma.
This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to August 2017.Firstly, All patients included will provide written informed consent. Secondly, they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD regimen arm 2. In total, 47 patients per arm (or 94 in total) are required. The treatment consists of four 4-week cycles of induction therapy followed by intensive therapy with another five modified VCD regimens and maintenance treatment with CP regimen. Then, patients will be followed up for 24 months after chemotherapy. The investigators will record all the laboratory and clinical investigations to assess response at different points of the study. We also monitor and assess adverse events (AEs), as graded according to NCI-CTCAE Version 3.0.Response categories were based on the International Myeloma Working Group uniform response criteria.In addition, 20 patients (10 in VCD regimen arm 1 group, 10 in VCD regimen arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib, cyclophosphamide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade
Induction therapy：1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,4 cycle Intensive therapy：1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,5 cycles.
cyclophosphamideDrug
Also called Endoxan, Cytoxan, Neosar, Procytox, Revimmune
Induction therapy：300mg/m2 VD Days 1-3 of each 28 day cycles,4 cycles. Intensive therapy：300mg/m2 VD Days 1-3 of each 28 day cycles,5 cycles. Maintenance treatment with CP: 200mg PO Days 1-14 of each 28 day cycles,12 cycles.
DexamethasoneDrug
Also called Acidocont,Deronil,Dexacortal,dexametona,Flumeprednisolon
Induction therapy：40 mg/d VD Days 1,6,11,16 of each 28 day cycles,4 cycles Intensive therapy：40 mg/d VD Days 1,6,11,16 of each 28 day cycles,5 cycles.
| Study group | Role | What they receive |
|---|---|---|
| modified VCD regimen1 | Experimental | Induction therapy：modified VCD regimen1 for 4 cycles,28 Days per Cycle.Intensive therapy：modified VCD regimen1 for 5 cycles.
Maintenance treatment:CP for 12 cycles. Interval between every two cycles for one month.
Interventions:
Drug: Bortezomib 1.6mg/m2 SC,Days 1, 6, 11, 16; Drug:Cyclophosphamide 300mg/m2 VD,Days 1-3; Drug: Dexamethasone 40 mg/d VD,Days 1, 6, 11,16; We undertook a pharmacodynamic substudy at selected sites. Blood samples were collected in cycle 1 on day 1, 6,11,16 before the dose was given and at several time points after dosing. We analysed whole blood samples to measure 20S proteasome chymotryptic activity, with a standard method. Pharmacodynamic parameters were calculated by analysis of percentage inhibition of 20S proteasome activity-time data. Receives: Drug: Bortezomib; Drug: cyclophosphamide; Drug: Dexamethasone |
| modified VCD regimen2 | Experimental | Induction therapy：modified VCD regimen1 for 4 cycles,28 Days per Cycle.Intensive therapy：modified VCD regimen 2 for 5 cycles.
Maintenance treatment:CP for 12 cycles. Interval between every two cycles for one month.
Interventions:
Drug: Bortezomib 1.3mg/m2 SC,Days 1, 6, 11, 16; Drug:Cyclophosphamide 300mg/m2 VD,Days 1-3; Drug: Dexamethasone 40 mg/d VD,Days 1, 6, 11,16; We undertook a pharmacodynamic substudy at selected sites. Blood samples were collected in cycle 1 on day 1, 6,11,16 before the dose was given and at several time points after dosing. We analysed whole blood samples to measure 20S proteasome chymotryptic activity, with a standard method. Pharmacodynamic parameters were calculated by analysis of percentage inhibition of 20S proteasome activity-time data. Receives: Drug: Bortezomib; Drug: cyclophosphamide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of complete remission
The rate of complete remission of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
Measured: Day 1 of every treatment cycle
Secondary outcomes (5)
progression free survival
PFS of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
Measured: up to two year
Adverse Events
Adverse events (AEs) were graded according to NCI-CTCAE Version 4.0
Measured: up to two years
overall response rates (ORR)
The rate of overall response of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
Measured: Day 1 of every treatment cycle
duration of response
Duration of response of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
Measured: up to 6 months
overall survival (OS)
The rate of OS of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
Measured: up to two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongping Zhai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongping Zhai, Jinling Hospital, China
- Investigators
- zhai yo ping, doctor, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086942
- Sponsor's protocol ID
- NAB20130806
- Status last verified
- Aug 2017
- First submitted
- 12 Mar 2014
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Li F, Yao FS, Zhu XJ, Gu WY, Wang XH, Chen B, Huang DP, Ding JH, Wu TQ, Zhu Y, Zhao Q, Tang YM, Song P, Zhou XG, An ZM, Guo X, Wang XL, Zhong L, Xie XB, Zhai YP. A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients. J Cancer Res Clin Oncol. 2019 Sep;145(9):2343-2355. doi: 10.1007/s00432-019-02967-3. Epub 2019 Jul 6.
PubMed 31280348
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT02086942
- Acronym / sponsor ID
- NAB20130806
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Yongping ZhaiUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to August 2017.Firstly, All patients included will provide written informed consent. Secondly, they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD regimen arm 2. In total, 47 patients per arm (or 94 in total) are required. The treatment consists of four 4-week cycles of induction therapy followed by intensive therapy with another five modified VCD regimens and maintenance treatment with CP regimen. Then, patients will be followed up for 24 months after chemotherapy. The investigators will record all the laboratory and clinical investigations to assess response at different points of the study. We also monitor and assess adverse events (AEs), as graded according to NCI-CTCAE Version 3.0.Response categories were based on the International Myeloma Working Group uniform response criteria.In addition, 20 patients (10 in VCD regimen arm 1 group, 10 in VCD regimen arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified VCD regimen1 | Experimental | Drug: Bortezomib, Drug: cyclophosphamide, Drug: DexamethasoneInduction therapy：modified VCD regimen1 for 4 cycles,28 Days per Cycle.Intensive therapy：modified VCD regimen1 for 5 cycles. Maintenance treatment:CP for 12 cycles. Interval between every two cycles for one month. Interventions: Drug: Bortezomib 1.6mg/m2 SC,Days 1, 6, 11, 16; Drug:Cyclophosphamide 300mg/m2 VD,Days 1-3; Drug: Dexamethasone 40 mg/d VD,Days 1, 6, 11,16; We undertook a pharmacodynamic substudy at selected sites. Blood samples were collected in cycle 1 on day 1, 6,11,16 before the dose was given and at several time points after dosing. We analysed whole blood samples to measure 20S proteasome chymotryptic activity, with a standard method. Pharmacodynamic parameters were calculated by analysis of percentage inhibition of 20S proteasome activity-time data. |
| modified VCD regimen2 | Experimental | Drug: Bortezomib, Drug: cyclophosphamide, Drug: DexamethasoneInduction therapy：modified VCD regimen1 for 4 cycles,28 Days per Cycle.Intensive therapy：modified VCD regimen 2 for 5 cycles. Maintenance treatment:CP for 12 cycles. Interval between every two cycles for one month. Interventions: Drug: Bortezomib 1.3mg/m2 SC,Days 1, 6, 11, 16; Drug:Cyclophosphamide 300mg/m2 VD,Days 1-3; Drug: Dexamethasone 40 mg/d VD,Days 1, 6, 11,16; We undertook a pharmacodynamic substudy at selected sites. Blood samples were collected in cycle 1 on day 1, 6,11,16 before the dose was given and at several time points after dosing. We analysed whole blood samples to measure 20S proteasome chymotryptic activity, with a standard method. Pharmacodynamic parameters were calculated by analysis of percentage inhibition of 20S proteasome activity-time data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with previously untreated symptomatic MM
- 18 years of age or older, regardless of gender
- secretory MM with measurable diseases
- Karnofsky Performance Status≥50%（pathological fractures excluded）
- Patients without heart and pulmonary dysfunction ≤class I
Key exclusion criteria (6 listed)
- peripheral neuropathy of grade 2 or higher according to NCI-CTCAE Version 3.0
- Relapse and refractory MM
- MM without symptom
- Non-secretory MM without measurable diseases
- Karnofsky Performance Status<50%（pathological fractures excluded）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibAlso: VelcadeInduction therapy：1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,4 cycle Intensive therapy：1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,5 cycles. | Drug | modified VCD regimen1, modified VCD regimen2 |
| cyclophosphamideAlso: Endoxan, Cytoxan, Neosar, Procytox, RevimmuneInduction therapy：300mg/m2 VD Days 1-3 of each 28 day cycles,4 cycles. Intensive therapy：300mg/m2 VD Days 1-3 of each 28 day cycles,5 cycles. Maintenance treatment with CP: 200mg PO Days 1-14 of each 28 day cycles,12 cycles. | Drug | modified VCD regimen1, modified VCD regimen2 |
| DexamethasoneAlso: Acidocont,Deronil,Dexacortal,dexametona,FlumeprednisolonInduction therapy：40 mg/d VD Days 1,6,11,16 of each 28 day cycles,4 cycles Intensive therapy：40 mg/d VD Days 1,6,11,16 of each 28 day cycles,5 cycles. | Drug | modified VCD regimen1, modified VCD regimen2 |
Primary outcome
the rate of complete remission
Time frame: Day 1 of every treatment cycle
The rate of complete remission of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.
5 secondary outcomes
progression free survival
Time frame: up to two year
Adverse Events
Time frame: up to two years
overall response rates (ORR)
Time frame: Day 1 of every treatment cycle
duration of response
Time frame: up to 6 months
overall survival (OS)
Time frame: up to two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Derived from this study: PubMed 31280348Li F, Yao FS, Zhu XJ, Gu WY, Wang XH, Chen B, Huang DP, Ding JH, Wu TQ, Zhu Y, Zhao Q, Tang YM, Song P, Zhou XG, An ZM, Guo X, Wang XL, Zhong L, Xie XB, Zhai YP. A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients. J Cancer Res Clin Oncol. 2019 Sep;145(9):2343-2355. doi: 10.1007/s00432-019-02967-3. Epub 2019 Jul 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhai yo ping, doctor principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib, cyclophosphamide and Dexamethasone in people with Multiple Myeloma, run by Yongping Zhai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhai yo ping, doctor (13951947646, zhaiyongping66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of complete remission (time frame: Day 1 of every treatment cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.